Device recall
Z-0257-2013: ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile…
FDA device recall · Class II · Kimberly-Clark Corporation
Key facts
| Recall number (Z-number) | Z-0257-2013 |
|---|---|
| Recall event | 63598 |
| Product | ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. |
| Product code | KKX |
| Recalling firm | Kimberly-Clark Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 13, 2013 |
| 510(k) numbers | K103406, K842115 |
| FEI number | 1000015879 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database